MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIATORR® TIPS ENDOPROSTHESIS; SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS

Catalog Number PT107275

Device Problem Insufficient Information (3190)

Patient Problems Liver Contusion (1953); Renal Failure (2041); Thrombus (2101); Stenosis (2263); Toxicity (2333)

Event Date 05/30/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).According to the gore viatorr tips endoprosthesis instruction for use (ifu) adverse events may include but are not limited to liver failure.

Event Description

It was reported to gore the following: the patient presented with a portal hypertension which was intended to be treated with a gore viatorr tips endoprosthesis on (b)(6) 2016.The procedure was aborted due to multiple unsuccessful puncture attempts.On (b)(6) 2016 the patient underwent an additional implantation procedure with a gore viatorr tips endoprosthesis.The procedure was finalized successful.The final angiography showed a good flow and a good preserved perfusion of the portal vein branches in both hepatic lobes.Before implantation of the gore viatorr tips endoprosthesis the portal systemic pressure gradient showed 15 mm hg.After implantation of the gore viatorr tips endoprosthesis the gradient showed a reduction to 10mm hg.On (b)(6) 2016 the computed tomography of the abdomen showed a subtotal stenosis of a dorsal portal vein branch in the right hepatic lobe.Maybe caused by the covered stent portion and as well a small intraluminal thrombus in the proximal vessel section.Resultant in an irregular configured and hypodense liver infarction in segment vi and vii.The device is in the location as intended and without any signs of stenosis or occlusion.In addition the patient suffered from acute renal insufficiency and hyperkalemia.Laboratory parameters confirmed the liver infarction.On (b)(6) 2016 the patient was discharged a stable constitution.

Manufacturer Narrative

(b)(6), lot 14051338, (b)(4).

• Brand Name: GORE VIATORR® TIPS ENDOPROSTHESIS
• Type of Device: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: ruth kunzmann ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5821279
• MDR Text Key: 50403443
• Report Number: 3007284313-2016-00134
• Device Sequence Number: 1
• Product Code: MIR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P040027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2018
• Device Catalogue Number: PT107275
• Device Lot Number: 14051338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 60 YR